80 FR 68542 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 214 (November 5, 2015)

Page Range		68542-68543
FR Document		2015-28154

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed extension of the Laboratory Response Network information collection.

Federal Register, Volume 80 Issue 214 (Thursday, November 5, 2015)

[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68542-68543]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-28154]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0850; Docket No. CDC-2015-0093]

Proposed Data Collection Submitted for Public Comment and
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on the proposed
extension of the Laboratory Response Network information collection.

DATES: Written comments must be received on or before January 4, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0093 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the
instructions for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE., MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.

Please note: All public comment should be submitted through the
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: omb@cdc.gov.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; to develop, acquire,
install and utilize technology and systems for the purpose of
collecting, validating and verifying information, processing and
maintaining information, and disclosing and providing information; to
train personnel and to be able to respond to a collection of
information, to search data sources, to complete and review the
collection of information; and to transmit or otherwise disclose the
information.

Proposed Project

Laboratory Response Network--Extension--(OMB Control No. 0920-0850,
expires April 30, 2016), National Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).

Background and Brief Description

The Laboratory Response Network (LRN) was established by the
Department of Health and Human Services (HHS), Centers for Disease
Control and Prevention (CDC) in accordance with Presidential Decision
Directive 39, which outlined national anti-terrorism policies and
assigned specific missions to Federal departments and agencies. The
LRN's mission is to maintain an integrated national and international
network of laboratories that can respond to suspected acts of
biological, chemical, or radiological threats and other public health
emergencies.
When Federal, State and local public health laboratories
voluntarily join the LRN, they assume specific responsibilities and are
required to provide information to the LRN Program Office at CDC. Each
laboratory must submit and maintain complete information regarding the
testing capabilities of the laboratory. Biennually, laboratories are
required to review, verify and update their testing capability
information. Complete testing capability information is required in
order for the LRN Program Office to determine the ability of the
Network to respond to a biological or chemical threat event. The
sensitivity of all information associated with the LRN requires the LRN
Program Office to obtain personal information about all individuals
accessing the LRN Web site. In addition, the LRN Program Office must be
able to contact all laboratory personnel during an event so each
laboratory staff member that obtains access to the restricted LRN Web
site must provide his or her contact information to the LRN Program
Office.
As a requirement of membership, LRN Laboratories must report all
biological and chemical testing results to the LRN Program at CDC using
a CDC developed software tool called the LRN Results Messenger. This
information is essential for surveillance of anomalies, to support
response to an event that may involve multiple agencies and to manage
limited resources. LRN Laboratories must also participate in and report
results for Proficiency Testing Challenges or Validation Studies. LRN
Laboratories participate in multiple Proficiency

[[Page 68543]]

Testing Challenges, Exercises and/or Validation Studies every year
consisting of five to 500 simulated samples provided by the LRN Program
Office. It is necessary to conduct such challenges in order to verify
the testing capability of the LRN Laboratories. The rarity of
biological or chemical agents perceived to be of bioterrorism concern
prevents some LRN Laboratories from maintaining proficiency as a result
of day-to-day testing. Simulated samples are therefore distributed to
ensure proficiency across the LRN. The results obtained from testing
these simulated samples must also be entered into Results Messenger for
evaluation by the LRN Program Office.
During a surge event resulting from a bioterrorism or chemical
terrorism attack, LRN Laboratories are also required to submit all
testing results using LRN Results Messenger. The LRN Program Office
requires these results in order to track the progression of a
bioterrorism event and respond in the most efficient and effective way
possible and for data sharing with other Federal partners involved in
the response. The number of samples tested during a response to a
possible event could range from 10,000 to more than 500,000 samples
depending on the length and breadth of the event. Since there is
potentially a large range in the number of samples for a surge event,
CDC estimates the annualized burden for this event will be 2,250,000
hours or 625 responses per respondent.
There is no cost to the respondents other than their time. The
total estimated annualized burden is 2,382,300 hours.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average number
Number of of responses Average burden Total burden
Respondents Forms respondents per per response hours
respondent (hours)
----------------------------------------------------------------------------------------------------------------
Public Health Laboratories.... Biennial 150 1 2 300
Requalification.
Public Health Laboratories.... General 150 25 24 90,000
Surveillance
Testing Results.
Public Health Laboratories.... Proficiency 150 5 56 42,000
Testing/
Validation
Testing Results.
Public Health Laboratories.... Surge Event 150 625 24 2,250,000
Testing Results.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 2,382,300
----------------------------------------------------------------------------------------------------------------

Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-28154 Filed 11-4-15; 8:45 am]
BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 214 / Thursday, November 5, 2015 / Notices 68543

Testing Challenges, Exercises and/or obtained from testing these simulated number of samples tested during a
Validation Studies every year consisting samples must also be entered into response to a possible event could range
of five to 500 simulated samples Results Messenger for evaluation by the from 10,000 to more than 500,000
provided by the LRN Program Office. It LRN Program Office. samples depending on the length and
is necessary to conduct such challenges During a surge event resulting from a breadth of the event. Since there is
in order to verify the testing capability bioterrorism or chemical terrorism potentially a large range in the number
of the LRN Laboratories. The rarity of attack, LRN Laboratories are also of samples for a surge event, CDC
biological or chemical agents perceived required to submit all testing results estimates the annualized burden for this
using LRN Results Messenger. The LRN
to be of bioterrorism concern prevents event will be 2,250,000 hours or 625
Program Office requires these results in
some LRN Laboratories from responses per respondent.
order to track the progression of a
maintaining proficiency as a result of bioterrorism event and respond in the There is no cost to the respondents
day-to-day testing. Simulated samples most efficient and effective way possible other than their time. The total
are therefore distributed to ensure and for data sharing with other Federal estimated annualized burden is
proficiency across the LRN. The results partners involved in the response. The 2,382,300 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Average
Number of number of burden per Total burden
Respondents Forms respondents responses per response hours
respondent (hours)

Public Health Laboratories ................ Biennial Requalification .................... 150 1 2 300
Public Health Laboratories ................ General Surveillance Testing Re- 150 25 24 90,000
sults.
Public Health Laboratories ................ Proficiency Testing/Validation Test- 150 5 56 42,000
ing Results.
Public Health Laboratories ................ Surge Event Testing Results ........... 150 625 24 2,250,000

Total ........................................... ........................................................... ........................ ........................ ........................ 2,382,300

Leroy A. Richardson, comment on a proposed information FOR FURTHER INFORMATION CONTACT: To
Chief, Information Collection Review Office, collection entitled ‘‘Monitoring and request more information on the
Office of Scientific Integrity, Office of the Reporting for the Core State Violence proposed project or to obtain a copy of
Associate Director for Science, Office of the and Injury Prevention Program the information collection plan and
Director, Centers for Disease Control and Cooperative Agreement.’’ CDC will use instruments, contact the Information
Prevention. the information collected to monitor Collection Review Office, Centers for
[FR Doc. 2015–28154 Filed 11–4–15; 8:45 am] cooperative agreement awardees and to Disease Control and Prevention, 1600
BILLING CODE 4163–18–P identify challenges to program Clifton Road NE., MS–D74, Atlanta,
implementation and achievement of Georgia 30329; phone: 404–639–7570;
outcomes. Email: omb@cdc.gov.
DEPARTMENT OF HEALTH AND
DATES: Written comments must be SUPPLEMENTARY INFORMATION: Under the
HUMAN SERVICES
received on or before January 4, 2016. Paperwork Reduction Act of 1995 (PRA)
Centers for Disease Control and (44 U.S.C. 3501–3520), Federal agencies
ADDRESSES: You may submit comments, must obtain approval from the Office of
Prevention identified by Docket No. CDC–2015– Management and Budget (OMB) for each
[60Day–16–16BX; Docket No. CDC–2015– 0092 by any of the following methods: collection of information they conduct
0092] Federal eRulemaking Portal: or sponsor. In addition, the PRA also
Regulation.gov. Follow the instructions requires Federal agencies to provide a
Proposed Data Collection Submitted for submitting comments. 60-day notice in the Federal Register
for Public Comment and Mail: Leroy A. Richardson, concerning each proposed collection of
Recommendations Information Collection Review Office, information, including each new
AGENCY: Centers for Disease Control and Centers for Disease Control and proposed collection, each proposed
Prevention (CDC), Department of Health Prevention, 1600 Clifton Road NE., MS– extension of existing collection of
and Human Services (HHS). D74, Atlanta, Georgia 30329. information, and each reinstatement of
ACTION: Notice with comment period. Instructions: All submissions received previously approved information
must include the agency name and collection before submitting the
SUMMARY: The Centers for Disease Docket Number. All relevant comments collection to OMB for approval. To
Control and Prevention (CDC), as part of received will be posted without change comply with this requirement, we are
its continuing efforts to reduce public to Regulations.gov, including any publishing this notice of a proposed
burden and maximize the utility of personal information provided. For
jstallworth on DSK7TPTVN1PROD with NOTICES

data collection as described below.
government information, invites the access to the docket to read background Comments are invited on: (a) Whether
general public and other Federal documents or comments received, go to the proposed collection of information
agencies to take this opportunity to Regulations.gov. is necessary for the proper performance
comment on proposed and/or Please note: All public comment should be of the functions of the agency, including
continuing information collections, as submitted through the Federal eRulemaking whether the information shall have
required by the Paperwork Reduction portal (Regulations.gov) or by U.S. mail to the practical utility; (b) the accuracy of the
Act of 1995. This notice invites address listed above. agency’s estimate of the burden of the

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Document Created: 2015-12-14 15:03:56
Document Modified: 2015-12-14 15:03:56

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before January 4, 2016.
Contact		To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation		80 FR 68542

80 FR 68542 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 214 (November 5, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention